Status:
TERMINATED
Management of Common Bile Duct (CBD) Stones at Laparoscopic Cholecystectomy
Lead Sponsor:
South West Sydney Local Health District
Collaborating Sponsors:
Catholic Health Care Services
Greater Western Area Health Service
Conditions:
Choledocholithiasis
Cholelithiasis
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
This study is designed to assess whether a new technique called facilitated endoscopic retrograde cholangiopancreatography (ERCP) is or is not superior to conventional ERCP for removing stones found i...
Detailed Description
Symptomatic gallstone disease is common. In the year July 2001-2002, laparoscopic cholecystectomy was performed on 5,235 patients in NSW public hospitals. Up to 18% of patients undergoing laparoscopic...
Eligibility Criteria
Inclusion
- The patient must be able to give informed consent preoperatively (i.e. elective procedures only)
- Patients at higher than normal risk of having CBD stones identified at OC. For example: \*CBD stones identified at ultrasound; \*Wide CBD (\>6mm) at ultrasound; \*Previous, recent, current cholangitis, jaundice, or biliary pancreatitis; or \*Abnormal AST and ALT levels (\>2 times normal).
Exclusion
- Pregnancy at time of surgery
- Patients not fit for surgery. For example: \*Those with acute cholecystitis or persistent obstructive jaundice; \*Patients who have had a previous ERCP and sphincterotomy; or \*Patients in whom intervention was not technically possible (eg. previous Billroth II gastrectomy).
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2015
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT00124033
Start Date
March 1 2004
End Date
December 1 2015
Last Update
September 11 2006
Active Locations (13)
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1
Bankstown-Lidcombe Hospital
Bankstown, New South Wales, Australia, 2200
2
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
3
Dubbo Base Hospital
Dubbo, New South Wales, Australia, 2830
4
Gosford Hospital
Gosford, New South Wales, Australia, 2250